BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1647768 · Received March 29, 2010

    Report

    Report Number
    3005168196-2010-00460
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    January 18, 2009
    Report Date
    March 10, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS DISCOVERED BY THE PENUMBRA CLINICAL TEAM WHILE VISITING A CLINICAL TRIAL SITE. THE INCIDENT WAS NEVER REPORTED TO PENUMBRA. THE DEVICE INVOLVED WAS A NEURON 070 FROM A LOT INVOLVED IN THE RECALL (Z-0001-2010). THE INCIDENT OCCURRED BEFORE THE RECALL WAS INITIATED. THE INCIDENT DID NOT RESULT IN ANY INJURY TO THE PATIENT. PENUMBRA COMPLETED THE RECALL AS OF 23DEC09. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. PER FDA GUIDANCE ON 28AUG09, CATHETER KINKS ARE REPORTABLE INCIDENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #1626-02.B, (LOT #L14102). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. ALL PARTS THAT FAILED INSPECTIONS HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. (B)(4).

    Description of Event or Problem · 1

    A NEURON 070 GUIDE CATHETER WAS ADVANCED INTO THE LEFT DISTAL CERVICAL ICA. A 026 REPERFUSION CATHETER WAS ADVANCED INTO THE GUIDE CATHETER. HOWEVER, A SIGNIFICANT KINK WAS PRESENT AT THE LEVEL OF THE AORTIC ARCH WHICH PROHIBITED ADVANCEMENT OF THE MICROCATHETER. THE GUIDE CATHETER AND MICROCATHETER WERE REMOVED. A NEURON 053 GUIDE CATHETER WAS ADVANCED INTO THE DISTAL CERVICAL LEFT ICA. UTILIZING ROAD MAP TECHNIQUE, A 026 REPERFUSION CATHETER WAS ADVANCED INTO THE LEFT MCA OVER A 0.014 GUIDEWIRE AND SUBSEQUENTLY INTO THE ANTERIOR DIVISION. NO APPARENT PATIENT INJURY RESULTED FROM THE KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14102

    Patients

    Seq Age Sex Outcome Treatment
    1